Showing papers by "Fred H. Edwards published in 2016"
TL;DR: This model should be a valuable adjunct for patient counseling, local quality improvement, and national monitoring for appropriateness of selection of patients for TAVR.
Abstract: Importance Patient selection for transcatheter aortic valve replacement (TAVR) should include assessment of the risks of TAVR compared with surgical aortic valve replacement (SAVR). Existing SAVR risk models accurately predict the risks for the population undergoing SAVR, but comparable models to predict risk for patients undergoing TAVR are currently not available and should be derived from a population that underwent TAVR. Objective To use a national population of patients undergoing TAVR to develop a statistical model that will predict in-hospital mortality after TAVR. Design, Setting, and Participants Patient data were obtained from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry. The model was developed from 13 718 consecutive US patients undergoing TAVR in centers participating in the STS/ACC TVT Registry from November 1, 2011, to February 28, 2014. Validation was conducted using 6868 records of consecutive patients undergoing TAVR from March 1 to October 8, 2014. Covariates were selected through a process of expert opinion and statistical analysis. The association between in-hospital mortality and baseline covariates was estimated using logistic regression. The final set of predictors was selected via stepwise variable selection. Data were collected and analyzed from November 1, 2011, to February 28, 2014. Main Outcomes and Measures In-hospital TAVR mortality. Results The development sample included 13 718 patient records from 265 participant sites (of 13 672 with data available, 6680 men [48.9%]; 6992 women [51.1%]; mean [SD] age, 82.1 [8.3] years). The final validation cohort included 6868 patients from 314 participating centers (3554 men [51.7%]; 3314 women [48.3%]; mean [SD] age, 81.6 [8.8] years). In-hospital mortality occurred in 730 patients (5.3%). The C statistic for discrimination was 0.67 (95% CI, 0.65-0.69) in the development group and 0.66 (95% CI, 0.62-0.69) in the validation group. The final model covariates (reported as odds ratios; 95% CIs) were age (1.13; 1.06-1.20), glomerular filtration rate per 5-U increments (0.93; 0.91-0.95), hemodialysis (3.25; 2.42-4.37), New York Heart Association functional class IV (1.25; 1.03-1.52), severe chronic lung disease (1.67; 1.35-2.05), nonfemoral access site (1.96; 1.65- 2.33), and procedural acuity categories 2 (1.57; 1.20-2.05), 3 (2.70; 2.05-3.55), and 4 (3.34; 1.59-7.02). Calibration analysis demonstrated no significant difference between the model (predicted vs observed) calibration line (−0.18 and 0.97 for intercept and slope, respectively) compared with the ideal calibration line. Conclusions and Relevance Data from the STS/ACC TVT Registry have been used to develop a predictive model of in-hospital mortality for patients undergoing TAVR. Validation based on a population of patient records not used in model development demonstrates discrimination and calibration indices that are more favorable than other models used in populations with TAVR. This model should be a valuable adjunct for patient counseling, local quality improvement, and national monitoring for appropriateness of selection of patients for TAVR.
218 citations
TL;DR: The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice and can be used to identify trends in practice and opportunities for quality improvement.
172 citations
TL;DR: Gait speed is an independent predictor of adverse outcomes after cardiac surgery, and can be used to refine estimates of operative risk, to support decision-making and, since incremental value is modest when used as a sole criterion for frailty, to screen older adults who could benefit from further assessment.
Abstract: Importance Prediction of operative risk is a critical step in decision making for cardiac surgery. Existing risk models may be improved by integrating a measure of frailty, such as 5-m gait speed, to better capture the heterogeneity of the older adult population. Objective To determine the association of 5-m gait speed with operative mortality and morbidity in older adults undergoing cardiac surgery. Design, Setting, and Participants A prospective cohort study was conducted from July 1, 2011, to March 31, 2014, at 109 centers participating in the Society of Thoracic Surgeons Adult Cardiac Surgery Database. The 5-m gait speed test was performed in 15 171 patients aged 60 years or older undergoing coronary artery bypass graft, aortic valve surgery, mitral valve surgery, or combined procedures. Main Outcomes and Measures All-cause mortality during the first 30 days after surgery; secondarily, a composite outcome of mortality or major morbidity during the index hospitalization. Results Among the cohort of 15 171 patients undergoing cardiac surgery, the median age was 71 years and 4622 were female (30.5%). Compared with patients in the fastest gait speed tertile (>1.00 m/s), operative mortality was increased for those in the middle tertile (0.83-1.00 m/s; odds ratio [OR], 1.77; 95% CI, 1.34-2.34) and slowest tertile ( Conclusions and Relevance Gait speed is an independent predictor of adverse outcomes after cardiac surgery, with each 0.1-m/s decrease conferring an 11% relative increase in mortality. Gait speed can be used to refine estimates of operative risk, to support decision-making and, since incremental value is modest when used as a sole criterion for frailty, to screen older adults who could benefit from further assessment.
123 citations
University of Florida1, University of Kentucky2, Columbia University3, Carolinas Healthcare System4, Durham University5, Southern Illinois University Carbondale6, University of Michigan7, Baylor University Medical Center8, University of Pittsburgh9, Johns Hopkins University10, Medical College of Wisconsin11, Harvard University12
TL;DR: CABG mortality rates vary directly with FTR, but complication rates have little relation to death, and FTR rates derived from The Society of Thoracic Surgeons data can serve as national benchmarks.
83 citations
All Children's Hospital1, Johns Hopkins University School of Medicine2, Harvard University3, Duke University4, University of Pittsburgh5, University of Colorado Denver6, Baylor University Medical Center7, Columbia University8, Vanderbilt University9, University of Illinois at Chicago10, Baylor University11, Society of Thoracic Surgeons12, University of Florida13, University of Michigan14
TL;DR: Linkage of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database, and facilitates studying long-term outcomes and costs of cardiothoracic surgery.
74 citations
TL;DR: A TAVR in-hospital mortality risk model was developed and revealed variation in risk-adjusted mortality rates during the US early commercial experience, which will support research, feedback reporting, and the identification of factors associated with quality.
Abstract: Background—The use of transcatheter aortic valve replacement (TAVR) to treat aortic stenosis in the United States is growing, yet little is known about the variation in procedural outcomes in community practice. We developed a TAVR in-hospital mortality risk model and used it to quantify variation in mortality rates across United States (US) TAVR centers. Methods and Results—We analyzed data from 22 248 TAVR procedures performed at 318 sites participating in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 to October 2014). A Bayesian hierarchical model was developed to estimate hospital-specific risk-adjusted mortality rates adjusting for 40 patient baseline factors. A total of 1130 in-hospital deaths (5.1%) were observed. Reliability-adjusted risk-adjusted mortality rate estimates ranged from 3.4% to 7.7% with an interquartile range of 4.8% to 5.4%. A patient’s predicted odds of dying was 80% higher if treated by a hospital 1 standard de...
43 citations
TL;DR: The risks of procedural mortality and morbidity after coronary artery bypass surgery were higher among black patients than among white patients, and these differences were in part accounted for by patient comorbidities, socioeconomic status, and surgeon, hospital, and care factors.
Abstract: Background— Previous studies have reported that black patients undergoing coronary artery bypass surgery had worse outcomes than white patients, even after accounting for patient factors. The degree to which clinician, hospital, and care factors account for these outcome differences remains unclear. Methods and Results— We evaluated procedural outcomes in 11 697 blacks and 136 362 whites undergoing isolated coronary artery bypass surgery at 663 Society of Thoracic Surgery Database participating sites (January 1, 2010 to June 30, 2011) adjusted for patients’ clinical and socioeconomic features, hospital and surgeon effects, and care processes (internal mammary artery graft and perioperative medications use). Relative to whites, blacks undergoing coronary artery bypass surgery were younger, yet had higher comorbidities and more adverse presenting features. Blacks were also more likely to be treated at hospitals with higher risk-adjusted mortality. The use of internal mammary artery was marginally lower in blacks than in whites (93.3% versus 92.2%, P P P Conclusions— The risks of procedural mortality and morbidity after coronary artery bypass surgery were higher among black patients than among white patients. These differences were in part accounted for by patient comorbidities, socioeconomic status, and surgeon, hospital, and care factors, as well, as suggested by the reduction in the strength of the race-outcomes association. However, black race remained an independent predictor of outcomes even after accounting for these differences.
43 citations
All Children's Hospital1, Johns Hopkins University School of Medicine2, Harvard University3, University of Michigan4, University of Florida5, Society of Thoracic Surgeons6, Lahey Hospital & Medical Center7, University of Virginia8, West Virginia University9, Emory University10, Henry Ford Hospital11, University of Colorado Denver12, Duke University13, Washington University in St. Louis14, University of Pennsylvania15
TL;DR: This article provides a summary of the status of the STS National Database as of October 2016 and summarizes the articles about the STs National Database that appeared in The Annals of Thoracic Surgery 2016 series, "Outcomes Analysis, Quality Improvement, and Patient Safety."
34 citations
TL;DR: This report summarizes the ACSD-based research efforts published in 2015 and indicates that the risk-adjusted outcome analyses and quality measures reported in these studies have made substantial contributions to inform daily clinical practice.
15 citations
TL;DR: Use of the STS CHSD for outcomes research and for quality measurement continues to expand as database participation and the available wealth of data in it continue to grow.
14 citations
Harvard University1, Emory University2, Mayo Clinic3, University of Maryland, Baltimore4, University of Colorado Boulder5, Oregon Health & Science University6, Duke University7, Durham University8, Johns Hopkins University School of Medicine9, Washington University in St. Louis10, University of Florida11, Society of Thoracic Surgeons12
TL;DR: A lack of database variables specific for certain uncommon procedures limits the ability to study these operations; inclusion of clinical descriptors for selected infrequent but clinically important thoracic disorders is suggested.